Status:
COMPLETED
Safety Study of Immune System Modulator for Autoimmune Diseases
Lead Sponsor:
Artax Biopharma Inc
Collaborating Sponsors:
Simbec Research
ORION Clinical Services
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects.
Eligibility Criteria
Inclusion
- Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / \[Height (m)\]2.
- In good health as determined by medical history, physical examination, and clinical judgment of the investigator
- Subject with no history of autoimmune disease or cardiac disease
- Subjects must be available to complete the study (including follow-up visit).
- Subjects must satisfy a medical examiner about their fitness to participate in the study.
- Subjects must provide written informed consent to participate in the study.
Exclusion
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication within 21 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Subjects who are smokers, or ex-smokers who have smoked in the last 3 months (determined by negative urine cotinine at screening visit).
- A clinically significant history of hypersensitivity (anaphylaxis, angioedema) to any drug.
- A clinically significant history of drug or alcohol abuse.
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02243683
Start Date
September 1 2014
End Date
March 1 2015
Last Update
October 14 2015
Active Locations (1)
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1
Simbec Research Ltd
Merthyr Tydfil, Cardiff Road, United Kingdom, CF48 4DR